EUDAMED last updated this device on May 18, 2026

Shun Fountain 1

B-06956014471319

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Shunmei Medical Co.,Ltd
UDI-DI code: 06956014471319
Reference / catalog number: 617131

Shun Fountain 1 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Shunmei Medical Co.,Ltd. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 18, 2026

Shun Fountain 1

B-06956014471319

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Shunmei Medical Co.,Ltd
UDI-DI code: 06956014471319
Reference / catalog number: 617131

View device family (Basic UDI)

Device identification

Trade name: Shun Fountain 1
UDI-DI code: 06956014471319
Basic UDI-DI: B-06956014471319
Reference / catalog number: 617131
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06956014471319

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A02010401SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Türkiye; available across 32 countries total.

Country	On market since	Until
TürkiyePrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
XI		Still on market

Device identification

Trade name: Shun Fountain 1
UDI-DI code: 06956014471319
Basic UDI-DI: B-06956014471319
Reference / catalog number: 617131
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Shunmei Medical Co.,Ltd
SRN: CN-MF-000001160
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06956014471319

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A02010401SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

M.2025.MDR.1078Amended
Quality management systemNotified body: 2696Expiry: May 15, 2028
M.2025.MDR.2017Amended
Technical documentationNotified body: 2696Expiry: May 15, 2028
2QMS-MDR-0061/03/2026Withdrawn
Quality management systemNotified body: 2764Expiry: Mar 10, 2029
1TD-MDR-0061/03/2026/01Issued
Technical documentationNotified body: 2764Expiry: Mar 10, 2029
1TD-MDR-0061/03/2026/03Issued
Technical documentationNotified body: 2764Expiry: Mar 10, 2029
1TD-MDR-0061/03/2026/02Issued
Technical documentationNotified body: 2764Expiry: Mar 10, 2029

Legacy certificates

Certificate number: HD 60147577 0001
Type: MDD Annex II (excl. §4)
Notified body: TÜV Rheinland LGA Products GmbH (0197)
Validity: May 26, 2024

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Shunmei Medical Co.,Ltd

Market distribution

Primary placement in Türkiye; available across 32 countries total.

Country	On market since	Until
TürkiyePrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
XI		Still on market

Shun Fountain 1

Shun Fountain 1

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

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